The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...

The FDA has granted a de novo clearance to a wearable device—with a form factor you’re familiar with—that can check patients ...

Optune Lua is FDA approved for use with immunotherapy or docetaxel in metastatic stage IV NSCLC post-platinum treatment. The device uses tumor treating fields to disrupt cancer cell division ...

We need more science in the FDA approval process.” Spotlighting the issue is a new study in the Annals of Internal Medicine looking at recalls of heart devices -- like pacemakers, stents ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

Medtech company DermaSensor has claimed FDA approval for a handheld device, powered by artificial intelligence (AI), that can be used to detect skin cancer at the point of care. The eponymous ...

Novocure received a long-sought FDA approval for the use of its Tumor Treating ... Its portable Optune Lua device, with arrays on adhesive patches worn on the chest or back, received a green ...

The FDA cleared the device for use with immunotherapy or chemotherapy in people whose cancer has spread and progressed following chemo. Approval was based on results from “Lunar,” a Phase 3 ...

A wearable technology is the latest addition to the treatment mix. The FDA has approved a Novocure medical device that uses fields of electricity to kill cancer cells. The regulatory decision anno ...

“Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss ...

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. Cognoa says the artificial ...